Kornimate/medical-research-clean huggingface dataset:
penetration and compartimentation of hiv

Conditions: HIV

Summary: genital mucosa is the main way of hiv penetration. many cells can be involved (epithelial cells, langerhans cells) and antibodies may also play a critical role. the investigators' study aims to precise the role of each type of cells, the interaction cell-cell and cell-antibodies.

at inclusion, men will have a two blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm and women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions

Eligibility criteria:
inclusion criteria: * adults (\> 18 year-old) hiv positive, * hiv-cv\> 1000 cp/ml, exclusion criteria: * children

Keywords: hiv patients genital hiv penetration
efficacy and safety of naldemedine in the treatment of opioid-induced constipation

Conditions: Opioid-induced Constipation

Summary: the purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (oic) in adults with non-malignant chronic pain who are not using laxatives.


Eligibility criteria:
inclusion criteria: 1. subjects aged 18 to 80 years inclusive at the time of informed consent 2. subjects must have non-malignant chronic pain treated with opioids and must have opioid-induced constipation (oic) 3. subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate 4. subjects must not be currently using laxatives or must be willing to discontinue laxative use at screening and must be willing to use only the rescue laxatives provided throughout the study duration 5. subjects must meet opioid-induced constipation criteria based on the bowel movement and constipation assessment (bmca) diary exclusion criteria: 1. evidence of significant structural abnormalities of the gastrointestinal (gi) tract 2. evidence of active medical diseases affecting bowel transit 3. history or presence of pelvic disorders that may be a cause of constipation 4. surgery (except for minor procedures) within 60 days of screening 5. history of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g., mechanical gi obstruction) 6. subjects who have never taken laxatives for the treatment of oic 7. history of active treatment for cancer within the last 2 years (except for basal cell or squamous cell carcinoma of the skin that have been successfully resected) or tamoxifen \[nolvadex®\] and raloxifene \[evista®\] when being used for prevention of breast cancer 8. current use of any prohibited medication including opioid antagonists, partial agonists or mixed agonists/antagonists

Keywords: opioid-induced constipation
incremental value of magnetic resonance imaging in selection of pancreatic cancer patients for surgery

Conditions: Pancreatic Cancer; Pancreatic Neoplasm; Liver Metastases

Summary: the aim of the study is to examine the incremental value of using magnetic resonance imaging (mri) in addition to computed tomography (ct) in the diagnostic workup of pancreatic cancer patients.

the aim of the study is to examine the incremental value of using magnetic resonance imaging (mri) in addition to computed tomography (ct) in the diagnostic workup of pancreatic cancer patients. we will conduct a nationwide, prospective clinical trial to examine the incremental value of using mri for identification of liver metastases in pancreatic cancer patients.

Eligibility criteria:
inclusion criteria: * pancreatic cancer patients considered to have a locally resectable or borderline resectable tumor by the local hepato-pancreato-biliary multidisciplinary team board * no liver metastases on ct * at least 18 years old and able to provide informed consent * expected pancreatic ductal adenocarcinoma based on ct scan exclusion criteria: * metastatic disease * prior receipt of neoadjuvant chemotherapy or downstaging/-sizing treatment * comorbidity rendering major surgery unfeasible (inoperable) * no informed consent * unable to undergo mri (kidney insufficiency (egfr \< 60 ml/min/1.73 m2 body surface ar-ea); claustrophobia; cardiac pacemaker) * postoperative histology other than adenocarcinoma of pancreato-biliary origin. * mri with liver-specific contrast performed during standard workup.

Keywords: magnetic resonance imaging
seric calprotectine in spondyloarthritis

Conditions: Spondylarthritis

Summary: to date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. a growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. in spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. still others have shown that it could be a predictive factor of radiological evolution in the same disease key. these data support, despite the questionable results of the klingberg study, the value of this dosage in spondyloarthritis. the objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. difficulties classically encountered in common practice in rheumatology.


Eligibility criteria:
inclusion criteria: * patients in the active line of the rheumatology department with one of the following criteria: * active spondyloarthritis (basdai \>4), * or spondyloarthritis in low activity (basdai\<4), * or fibromyalgia without associated inflammatory rheumatism, * or healthy subjects (without inflammatory rheumatism and without fibromyalgia. * patients who have not objected to the use of their samples exclusion criteria: * minor patient * subject not affiliated to the social security system * subject deprived of liberty * patient under guardianship or curatorship
ultrastructure analysis of excised internal limiting membrane in eyes of highly myopia with myopic traction maculopathy

Conditions: Myopic Traction Maculopathy

Summary: the excised ilm from 7 eyes of 7 patients with mtm including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ilm peeling was examined to evaluate ultrastructure with electron microscopy.


Eligibility criteria:
inclusion criteria: * the inclusion criteria were patients who underwent vitrectomy and internal limiting membrane peeling for myopic traction maculopathy and had a follow-up for more than 6 months. exclusion criteria: * the patients with follow-up less than 6 months

Keywords: myopic traction maculopathy
confirmatory study of bk1310 in healthy infants

Conditions: Tetanus; Diphtheria; Pertussis; Poliomyelitis; Bacterial Meningitis

Summary: the purpose of this study is to evaluate immunogenicity of bk1310 for all antigens (anti-prp, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of acthib® and tetrabik, as well as efficacy and safety, in healthy infants.


Eligibility criteria:
inclusion criteria: * healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months) * written informed consent is obtained from a legal guardian (parent) exclusion criteria: * possibility of anaphylaxis due to food or pharmaceuticals * with experience of hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis * with experience of hib, diphteria, pertussis, tetanus or polio vaccination. * participated in other studies within 12 weeks before obtaining consent * considered to be not eligible by the principal investigators (sub-investigators) of the enrollment additional screening criteria check may apply for qualification.

Keywords: haemophilus influenza type b adsorbed diphtheria-purified pertussis-tetanus- inactivate poliovirus combined vaccine hib dpt-ipv
a study to evaluate once daily low dose and high dose solabegron or placebo given for 12 weeks to treat women with symptoms of overactive bladder: sudden urge to urinate, frequent urination associated with wetting episodes (vel-2001)

Conditions: Overactive Bladder

Summary: this is a phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.


Eligibility criteria:
inclusion criteria: * adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, urgency urinary incontinence, and mixed incontinence. subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives). exclusion criteria: * subjects must have no history of pelvic or bladder disease, e.g., uterine prolapse, malignancy, prior surgery, or treatment with botulinum toxin. * diabetes insipidus or poorly controlled type 1 or type 2 diabetes mellitus * cardiac conditions: * prior cardiovascular events or procedures within 6 months of screening * congestive heart failure * abnormal ecg findings, including ecg qt correction interval (qtc) \> 470 msec at the screening visit * systolic blood pressure ≥ 180 mmhg or diastolic blood pressure ≥ 100 mmhg, or heart rate \> 100 beats per minute * abnormal tests of liver function * history of prior infection due to hiv or hepatitis b or hepatitis c virus * allergy or hypersensitivity to solabegron or mirabegron * women of childbearing potential: breastfeeding, pregnant, or actively trying to become pregnant * participation in a trial of an investigational or marketed drug ≤ 30 days prior to the screening visit or in any clinical trial of an investigational drug that may affect urinary function within 3 months prior to screening visit. * inability to read, understand, or complete study-related materials

Keywords: overactive bladder urinary conditions urgency urinary incontinence urgency micturitions
hemodynamic effects of dry sauna followed by cold water immersion in healthy subjects

Conditions: Blood Pressure; Arrhythmias

Summary: the purpose of this study is to determine the safety on sauna followed by cold water bath, a common practice in many countries, 30 healthy subjects aged 40 years and older will be at the montreal heart institute prevention and cardiac rehabilitation centre.

to determine the safety on sauna followed by cold water bath, a common practice in many countries, 30 healthy subjects aged 40 years and older will be at the montreal heart institute prevention and cardiac rehabilitation centre. a recent complete evaluation will have excluded any cardiac condition. subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. immediately after , subjects will be immersed in a cold water bath (icool , australia) at a temperature of 5 degrees celtius for approximately one minute. blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath. principal goal of study: to determine the safety of this practice. secondary goals of study: to measure the blood pressure response, heart rate, presence of arrythmyas, cardiac output and cerebral perfusion during both conditions. primary endpoint: change in systolic blood pressure from sauna (after 10 minutes ) to cold water (after one minute). physiologic measurements: continuous ecg monitoring, bp measurements at every 3 minutes during sauna and at one minute in the cold bath, gaz exchange with a portable equipment (cosmed k4), bioimpedance and cerebral perfusion with a single frontal nirs electrode.

Eligibility criteria:
inclusion criteria: * healthy women and men aged 40 and older with a recent complete medical evaluation including a normal resting ecg and a normal symptom-limited treadmill exercise test. exclusion criteria: * any cardiac condition, abnormal exercise test, hypertension, type i diabetes and presence of any medications that may affect blood pressure.

Keywords: sauna cold water bath
transcranial magnetic stimulation in bipolar depression

Conditions: Bipolar Affective Disorder

Summary: to compare antidepressant efficacy of left or right to sham repetitive transcranial magnetic stimulation (rtms) to determine if non-responders can become responders if treated on the other side of the hemisphere (rtms)

patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rtms. after 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. mood stabilizers will be continued throughout this trial.

Eligibility criteria:
inclusion criteria: * bipolar depression * no physical health problems exclusion criteria: * metal in head/neck or skull * history of epilepsy * pregnancy * pacemaker

Keywords: transcranial magnetic stimulation tms
efficacy of flag regimen for the treatment of patients with aml

Conditions: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Summary: the long-term efficacy of chemotherapy in patients with acute myeloid leukemia (aml) has been significantly improved in recent years. the combination of anthracycline plus cytarabine (ara-c) has been a standard induction regimen for patients with aml. however, the optimal consolidation therapy after induction chemotherapy has not reached a consensus. the flag regimen consisting of fludarabine and high-dose cytarabine combined with g-csf which is one of the first-line consolidation treatment options for relapsed and refractory aml. this study conducted a retrospective analysis of the intensive treatment of aml with the flag regimen from january 2007 to may 2018 in our hospital to evaluate the efficacy of the flag regimen. to provide the basis for the choice and timing of treatment for patients with aml treated with the flag regimen.


Eligibility criteria:
inclusion criteria: * patient more than 18 year old * de novo or secondary leukemia. * treated with flag regimen exclusion criteria: * acute promyelocytic leukemia (apl)

Keywords: flag
efficacy, safety and tolerability of azd6234 in participants living with overweight or obesity with type 2 diabetes who are on a stable dose of glp-1 receptor agonist

Conditions: Endocrinology; Diabetes, Type II; Obesity

Summary: this phase ii study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of azd6234 in adults with overweight or obesity and type 2 diabetes on stable glp-1 ra therapy.

this is a phase ii, randomised, parallel-group, double-blind, placebo-controlled, multi-centre study to assess the efficacy, safety, and tolerability of azd6234 compared with placebo, given once weekly as a subcutaneous (sc) injection, in adults living with overweight or obesity and type 2 diabetes who are on a stable dose of glp-1 ra. the study is being conducted across sites in the usa to evaluate the efficacy, safety, and tolerability of azd6234 in adults with overweight or obesity and type 2 diabetes on stable glp-1 ra therapy. a total of 64 participants, aged 18-75 with a bmi ≥ 27 kg/m², will be randomized to receive weekly subcutaneous injections of either azd6234 or a placebo, alongside their current glp-1 ra medication. the study involves a screening period and a treatment and follow-up period.

Eligibility criteria:
inclusion criteria: 1. be 18 to 75 years old at the time of signing the informed consent. 2. diagnosed with type 2 diabetes ≥ 180 days before screening. 3. hba1c value at screening of ≥ 7.0% (53 mmol/mol) and ≤ 10% (86 mmol/mol). 4. on a stable maintenance dose of an injectable glp-1 ra. 5. at screening, have a bmi ≥ 27 kg/m2 exclusion criteria: 1. has received treatment with prescription or non-prescription medication for weight loss within the last 3 months prior to screening (other than a glp-1 ra). 2. self-reported weight change of \> 5 % in the 3 months prior to screening. 3. diabetes mellitus that is not clearly type 2 diabetes. 4. use of insulin therapy for t2dm 5. previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier) 6. significant hepatobiliary disease (except for non-alcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) 8. impaired renal function defined as egfr ≤ 45 ml/minute/1.73m2 at screening

Keywords: diabetes, type ii obesity
impact in the medical care among the rheumatic diseases patients in a hospital in méxico during covid-19 pandemic

Conditions: Rheumatoid Arthritis; Quality of Life

Summary: the national institute of medical sciences and nutrition is a national reference center for rheumatic diseases that belongs to the national institutes of health, and has federal founding. more than 8,000 patients with a wide variety of rheumatologic diagnosis receive medical care. on march 2020, the who announced covid-19 outbreak a pandemic. the first case was registered in mexico on february 2020. in march 2020, the mexican government requested that our institution should restrict health care to exclusively covid-19 patients; accordingly, outpatient consultations were, and up to august 2020 still, hold on. meanwhile, when possible, the department of immunology and rheumatology has implemented an "on-demand", non-organized patient´s health care, through email and phone contact; nonetheless, and due to the middle-low socioeconomic status of most of our patients and limited technical resources available at our institution, the attempt has been challenging.

the aim objective of this project is to explore patients perception about access to medical care and to medications, access to communication with their primary rheumatologist and patients risk perception about covid-19 disease, for this a survey directed (questionnaire locally developed) will apply and to explore how the reintegration at the usual medical care has a positive impact in the patient´s disease activity, patient´s quality of life and psychopathology (depression, anxiety and posttraumatic stress).

Eligibility criteria:
inclusion criteria: * patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate exclusion criteria: * patients with a not confirmed rheumatic disease * patients lost to follow-up from the outpatient for \> 1 year period * patients with pregnancy plans
tick-borne encephalitis and possible borrelial serology

Conditions: Tick Borne Encephalitis; Lyme Disease

Summary: in europe, tick-borne encephalitis (tbe) virus causing tbe is transmitted by the bite of ixodes ricinus tick, which can also transmit lyme borreliae , the causative agent of lyme borreliosis (lb). since tbe and lb are both endemic with high incidence rates in slovenia, we should be attentive to the possibility of double infections. double infections with tbe virus and lyme borreliae were reported to occur rarely even in endemic countries, however reliable data on coinfection rates are rather limited. microbiological diagnosis of tbe virus infection is quite straightforward, and there is no specific therapy for tbe available so far. this markedly differs from borrelial infection, in which case interpretation of serological test results demands more caution, but there is highly efficient antibiotic treatment available for lb. this may lead to over prescribing of antibiotics to tbe patients with documented borrelial antibodies in serum indicating possible coinfection with lyme borreliae, but missing clinical or microbiological criteria for proven borrelial coinfection. approximately 10% of patients who had been treated appropriately for lb and about one third of patients after tbe report nonspecific subjective complaints, such as fatigue, headache, arthralgia, and myalgia, termed post-lyme and post-encephalitic symptoms, respectively. these may not be differentiated clearly from nonspecific symptoms occurring with a rather substantial incidence also in the general population. a trend of ascribing medically unexplained nonspecific subjective symptoms to lb in subjects with positive borrelial antibodies in serum puzzles the situation further. the aim of this prospective observational study was to assess the proportion and clinical implication of proven and possible coinfection with lyme borreliae in patients with tbe, and to evaluate the association between anti-borrelial antibiotic therapy and clinical outcome in the subgroup of patients with possible coinfection.


Eligibility criteria:
inclusion criteria: * age ≥18 years * admitted between january 2007 and december 2013 at the university medical centre ljubljana, slovenia * tick-borne encephalitis defined according to european criteria (febrile illness with symptoms and/or signs of meningitis or meningoencephalitis, cerebrospinal fluid (csf) pleocytosis (\>5 × 106 cells/l), and demonstration of acute tbe virus infection (the presence of specific tick-borne encephalitis virus igm and igg antibodies in serum or demonstration of intrathecal production of specific tbe virus igm and/or igg antibodies in patients previously vaccinated against tick-borne encephalitis) exclusion criteria: * lyme borreliosis in the past